Mindfulness for Irritable Bowel Syndrome (MIBS)

University of Oxford

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Mindfulness Based Cognitive Therapy (MBCT); Behavioral: Waiting Period

Study type: Interventional

Funder types: Other

Identifiers

NCT02794376

11626

Details and patient eligibility

About

This study investigates the effectiveness of a 6 week mindfulness intervention in reducing symptoms of Irritable Bowel Syndrome (IBS). All Participants will receive treatment. Participants will be randomly allocated to an immediate treatment group and a waiting list control group.

Enrollment: 67 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is willing and able to give informed consent for participation in the study.
• Diagnosed with IBS by Gastroenterologist or General Practioner (GP), meeting Rome III criteria for IBS, symptom onset at least 6 months prior to inclusion, discomfort or pain at least 2-3 days per month
• Participants speaks English fluently or at a native level
• Participant has normal or corrected to normal vision

Exclusion criteria

• Participant has insufficient manual dexterity for the computerized tasks
• Severe Diagnostic and Statistical Manual (DSM) Axis I or II psychiatric disorder (diagnosis of dementia, amnesia, delirium, a dissociative disorder, a personality disorder, schizophrenia or any other psychotic disorder, a substance-related or induced disorder (such as alcoholism), attention deficit hyperactivity disorder (ADHD), attention deficit disorder (ADD), primary diagnosis of obsessive compulsive disorder (OCD), current suicidality, regular non-suicidal self-injury.
• Recent bereavement (within one year)
• GI diagnosis other than IBS (IBD, coeliac disease, another FGID)
• Pregnancy
• No access to the internet
• Prior participation in an 8-week mindfulness course (MBSR, MBCT) or any other structured mindfulness training. Prior participation in Vipassana meditation courses. Regular meditation practice (meditating more than once per month).
• Not able or unwilling to commit to amount of practice (sessions and home practice).
• Participant is currently enrolled in another IBS treatment study (psychological or pharmacological).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Immediate Treatment Group

Experimental group

Description:

Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments.

Treatment:

Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

Delayed Treatment Group

Other group

Description:

Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.

Treatment:

Behavioral: Waiting Period

Behavioral: Mindfulness Based Cognitive Therapy (MBCT)